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FDA 510(k)

BRAND NAME *1-STEP PREGNANCY

K-Number: K973352 · 1997-10-27

ApplicantArmkel, LLC
Decision Date1997-10-27
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BRAND NAME *1-STEP PREGNANCY is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1997-10-27 under 510(k) number K973352. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAND NAME *1-STEP PREGNANCY?

BRAND NAME *1-STEP PREGNANCY is a medical device that received FDA 510(k) clearance on 1997-10-27. The listed applicant is Armkel, LLC. The 510(k) number is K973352.

When did BRAND NAME *1-STEP PREGNANCY receive FDA 510(k) clearance?

BRAND NAME *1-STEP PREGNANCY received FDA 510(k) clearance on 1997-10-27, under 510(k) number K973352.

Who is the listed applicant for BRAND NAME *1-STEP PREGNANCY?

The FDA 510(k) record lists Armkel, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRAND NAME *1-STEP PREGNANCY?

The FDA product code for BRAND NAME *1-STEP PREGNANCY is LCX.

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Other records listing Armkel, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K040866FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TESTK030258FIRST RESPONSE PREGNANCY TESTK023405TROJAN MINT TINGLE BRAND LATEX CONDOMSK013433TROJAN PASSION BERRY GELK013614TROJAN CRYSTAL CLEAR LIQUIDK001212TROJAN EXTRA LARGE LATEX CONDOM

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Related Devices (Code: LCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd.K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLCK242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test MidstreamNanjing Synthgene Medical Technology Co., Ltd.K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLCK241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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